The manufacture of drugs for test, examination, and analysis is a critical aspect of pharmaceutical research and development. This process involves the production of small quantities of drugs that are not intended for commercial sale but are used to evaluate their safety, efficacy, and quality. Such activities are essential in various stages of drug development, … Read more
The process of obtaining a license for the manufacture of drugs is governed by stringent regulations to ensure that only high-quality, safe, and effective drugs are produced. The regulatory authorities lay down specific conditions that must be met for the grant of a manufacturing license. Once granted, the license comes with various conditions that the … Read more
The manufacture and sale of drugs are critical areas regulated by pharmaceutical laws to ensure public safety, efficacy, and quality of medications. Various countries have specific laws and regulations that govern these activities, primarily to protect consumers from harmful or substandard drugs. This note provides a detailed overview of the prohibition of the manufacture and … Read more
The Drugs and Cosmetics Act, 1940, and its Rules, 1945, were established to regulate the import, manufacture, distribution, and sale of drugs and cosmetics in India. The primary objectives are: 1. Ensuring Safety, Efficacy, and Quality: To ensure that drugs and cosmetics sold in India are safe, effective, and of standard quality. 2. Regulation of … Read more
OTC Medications in India 1. Regulation: OTC medications in India are regulated by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The Central Drugs Standard Control Organization (CDSCO) oversees the regulation and approval of OTC medications, ensuring their safety, efficacy, and quality. 2. Availability: OTC medications are available for purchase … Read more
